China’s Premier Li Keqiang just signed the State Council Order No. 680, announcing the Decision on Modification of “Medical Device Regulation Policy” by the State Council, effective immediately. The State […]
We are monitoring closely the current initiative taken by CFDA to reform its registration and regulatory policies and believe this reform should positively impact medical device entry to China by US and international medtech companies:
On May 11, the CFDA released three documents for public comment aiming to reform clinical trial management; accelerate review and approval process; and implement full life-cycle management; for encouraging pharmaceutical and medical device Innovation. These three documents mark a big step forward for the CFDA in reforming the registration system for pharmaceutical and medical devices and reflect some of the major issues that the industry has been advocating on for decades. On May 12, the CFDA further released Policies on Protecting Innovator’s Interests for Encouraging Pharmaceutical and Medical Device Innovation, to establish a pharmaceutical patent linkage system and improve test data protection system. The systems and measures proposed in this draft provide more detailed regulations for enforcing existing measures, showing the CFDA’s determination in further strengthening IPR protection and creating an atmosphere that rewards innovation...
In this month, CFDA released three documents for public comment: 1) Policies on Reforming Clinical Trial Management for Encouraging Pharmaceutical and Medical Device Innovation; 2) Policies on Accelerating Review and Approval Process for Encouraging Pharmaceutical and Medical Device Innovation; 3) Polices on Implementing Full Life-Cycle Management for Encouraging Pharmaceutical and Medical Device Innovation. According to the CFDA, these three documents aim to further deepen registration reform, promote industrial upgrade and innovation in the pharmaceutical and medical device sector, and meet increasing clinical needs.
Contact China Med Device (CMD) team if you would like to know more about CFDA's registration and policy reform and get immediate help to accelerate your device's market entry in China. Please call us 978-390-4453 or email info@ChinaMedDevice.com.
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Industry Standards for 28 medical devices including “Disposable Plasmapheresis Centrifuge Apparatus” have been released by CFDA from May 2nd to May 12nd. If you need any detailed information regarding these guidelines and how […]